The ConcePTION project has validated a novel method to evaluate the quality of real-world pregnancy pharmacovigilance data. The validation is based on 186 case reports. The results are published in Drug Safety, and represents an advancement in how data on medication safety during pregnancy is collected and assessed.
Pregnant women are almost always excluded from clinical studies. This makes it challenging to gather reliable data on the safety of medications during pregnancy. Because of this, much of the available information relies on real-world reports of pregnant women’s experiences of medicine, where the information is collected from other sources than traditional clinical trials.
The researchers used quantitative methods to validate a new standardised tool to assess the quality of real-world pregnancy pharmacovigilance data. The team looked at spontaneous reports, existing literature, and data from different registries, including two Teratology Information Services in the United Kingdom and Switzerland, and the Dutch Pregnancy Drug Register.
According to Eugène van Puijenbroek, Physician and Clinical Pharmacologist at the Netherlands Pharmacovigilance Centre Lareb, the tool is the first pregnancy pharmacovigilance data method that is designed, validated and standardized specifically to assess the quality of clinical information in case reports.
“Our approach confers less inter-rater variability compared with a quality assessment by experts of pregnancy-related pharmacovigilance data,” Eugène van Puijenbroek concludes.
In short, this new method could improve the reliability of pharmacovigilance data. Ultimately enhancing the safety of medicinal products for pregnant women, and their children.
Do you want to know more? Read the paper here: van Rijt-Weetink, Y.R.J., Egberts, T.C.G., van Hunsel, F.P.A.M. et al. Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project. Drug Saf 47, 261–270 (2024). https://doi.org/10.1007/s40264-023-01389-y
By Fanny Klingvall
